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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name heater, breathing system w/wo controller (not humidifier or nebulizer
510(k) Number K150900
Device Name Flexicare Heated Wire Breathing Systems
Applicant
FLEXICARE MEDICAL LTD.
CYNON VALLEY BUSINESS PARK
MOUNTAIN ASH
MID GLAMORGAN,  GB CF45 4ER
Applicant Contact Joel Biddle
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number868.5270
Classification Product Code
BZE  
Subsequent Product Code
BTT  
Date Received04/03/2015
Decision Date 05/15/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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